Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-28 @ 8:07 AM
Study NCT ID:
NCT01977261
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2013-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Tibial Osteotomy for Osteoarthritis of the Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2013-10-25', 'studyFirstSubmitQcDate': '2013-10-30', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'one year', 'description': 'Number of participants with adverse events; infection, loss of correction, hardware removal, implant failure, pseudoarthrosis, peroneal nerve injury.'}], 'primaryOutcomes': [{'measure': 'The achievement of an overcorrection of valgus of 4°.', 'timeFrame': 'one year', 'description': 'The achieved correction will be determined on a whole leg radiograph.'}], 'secondaryOutcomes': [{'measure': 'Severity of pain', 'timeFrame': 'one year', 'description': 'Severity of pain will be measured with the visual analogue scale'}, {'measure': 'Knee function', 'timeFrame': 'one year', 'description': 'Knee function will be measured with the Hospital for Special Surgery score'}, {'measure': 'Walking distance', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.', 'detailedDescription': 'A prospective, randomised, controlled trial compared two different techniques of high tibial osteotomy with a lateral closing wedge or a medial opening wedge, stabilised by a Puddu plate. The clinical outcome and radiological results were examined at one year.\n\nThe primary outcome measure was the achievement of an overcorrection of valgus of 4°. Secondary outcome measures were the severity of pain (visual analogue scale), knee function (Hospital for Special Surgery score), and walking distance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radiological OA, medial joint pain and varus malalignment\n\nExclusion Criteria:\n\n* Symptomatic OA of the lateral compartment, rheumatoid arthritis, ROM \\<100, collateral ligament laxity, history of fracture of previous open operation of the lower limb and a flexion contracture \\> 10 degrees.'}, 'identificationModule': {'nctId': 'NCT01977261', 'acronym': 'HTO', 'briefTitle': 'High Tibial Osteotomy for Osteoarthritis of the Knee', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'High Tibial Osteotomy for Osteoarthritis of the Knee: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2001-HTO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Opening-wedge HTO', 'description': 'Opening-wedge high tibial osteotomy fixated with a Puddu-plate', 'interventionNames': ['Procedure: Opening-wedge HTO']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Closing-wedge HTO', 'description': 'Closing-wedge high tibial osteotomy fixated with 2 staples', 'interventionNames': ['Procedure: Closing-wedge HTO']}], 'interventions': [{'name': 'Opening-wedge HTO', 'type': 'PROCEDURE', 'otherNames': ['open wedge high tibial osteotomy'], 'description': 'Opening-wedge high tibial osteotomy fixated with a Puddu plate', 'armGroupLabels': ['Opening-wedge HTO']}, {'name': 'Closing-wedge HTO', 'type': 'PROCEDURE', 'otherNames': ['Closed wedge high tibial osteotomy'], 'description': 'Closing-wedge high tibial osteotomy fixated with two staples', 'armGroupLabels': ['Closing-wedge HTO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015 CE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Centre', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'T. Duivenvoorden', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}